C8-C26 branched and linear hydrocarbons – Distillates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-10-03 to 2006-10-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study according to relevant guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

481-740-5

EC Name:

-

Cas Number:

848301-67-7

Molecular formula:

main general molecular formula: CnH(2n+2)

IUPAC Name:

2,2,3,4,4,5,6-heptamethylheptane; 2,2,8-trimethyltetradecane; 2,2-dimethyldodecane; 2,2-dimethyltetradecane; 2-methyltetradecane; 3,5,7-triethyldecane; 4-ethyldodecane; 4-propyldodecane; 5,5-dipropylnonane; 5,7-dimethyl-4-propylundecane; 5-butyl-5-propyldecane; 5-butyl-5-propylnonane; 5-ethyl-5-propylnonane; 5-ethyl-7-methyl-4-propylundecane; 5-propyltridecane; 6-butyl-6-methyldodecane; 6-butyldodecane; 6-butylundecane; 7-methyl-4-propylundecane; 8-methyl-5-propyltridecane; 9-butyl-6-propylhexadecane; heptadecane; hexacosane; hexadecane; octane; pentadecane; tetradecane

Details on test material:

- Name of test material (as cited in study report): Distillates (Fischer-Tropsch), C8-26 branched and linear
- Substance type: Organic
- Physical state: Clear colorless liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Information not available
- Composition of test material, percentage of components: Information not available
- Isomers composition: Information not available
- Purity test date: Information not available
- Lot/batch No.: Information not available
- Expiration date of the lot/batch: Information not available
- Stability under test conditions: Stable under normal temperature and pressure
- Storage condition of test material: Room temperature, in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: At the start of the study the animals were eight to twelve weeks of age.
- Weight at study initiation: The bodyweights fell within an interval of i 20% of the initial bodyweight of the first treated animal.
- Fasting period before study: With the exception of an overnight fast immediately before dosing and for approximately three to four hours after
dosing, free access to mains drinking water and food (Certified Rat and Mouse Diet (Code SLF2) was allowed throughout the study.
- Housing: On receipt the animals were randomly allocated to cages.
- Diet (e.g. ad libitum): Overnight fast immediately before dosing and for approximately three to four hours after dosing (free access to mains
drinking water and food was allowed throughout the study).
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 19 to 25°C.
- Humidity (%): The relative humidity was set to achieve limits of 30 to 70%.
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Not applicable
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not applicable
- Purity: Not applicable

MAXIMUM DOSE VOLUME APPLIED:
5000 mg/kg

DOSAGE PREPARATION (if unusual):
Not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not applicable

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology: yes

Statistics:

No statistical procedures were applied.

Results and discussion

Preliminary study:

Following a preliminary test in which there were no deaths at a dose level of 5000 mg/kg, an additional 4 fasted Sprague-Dawley DC rats received a dose of 5000 mg of the undiluted test material per kg body weight by gavage.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

- Mortality: no deaths

Clinical signs:

other: - Clinical observations: no signs of systemic toxicity

Gross pathology:

- Necropsy: no abnormalities

Other findings:

None

Any other information on results incl. tables

Table 1: Individual Clinical Observations and Mortality Data

Dose level	Animal	Effects noted after dosing (hours)				Effects noted during period after dosing (days)
(mg/kg)	No.	0,5	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
5000	Female 1 -0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5000	Female 2 -0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5000	Female 2 -1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5000	Female 2 -2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5000	Female 2 -3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

0- No signs of systemic toxicity

Table 2: Individual Body weights and Bodyweight changes

Dose level	Animal	Bodyweight at day (g)			Body weight gain during week (g)
(mg/kg)	No.	Day 0	Day 7	Day 14	Day 1	Day 7
5000	Female 1 -0	213	247	268	34	21
5000	Female 2 -0	190	213	216	23	3
5000	Female 2 -1	216	251	273	35	22
5000	Female 2 -2	198	236	249	36	15
5000	Female 2 -3	206	229	238	23	9

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: other: Since the substance is composed of aliphatic hydrocarbons and has low viscosity, it may present an aspiration hazard in humans following oral exposure. It is therefore appropriate to classify the substance as ‘Harmful: may cause lung damage if swallowed’.

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight. Using the EU Globally Harmonised System (GHS), it would be ‘unclassified’. However, since the substance is composed of aliphatic
hydrocarbons and has low viscosity, it may present an aspiration hazard in humans following oral exposure. It is therefore appropriate to classify
the substance as ‘Harmful: may cause lung damage if swallowed’.

Executive summary:

'Distillates (Fischer-Tropsch), C8-26 branched and linear' was tested in an acute oral toxicity study according to the fixed dose method (OECD 420). Following a preliminary test in which there were no deaths at a dose level of 5000 mg/kg, an additional 4 fasted Sprague-Dawley DC rats received a dose of 5000 mg of the undiluted test material per kg body weight by gavage. There were no signs of toxicity, all animals showed normal gains in body weight, and there were no abnormalities on necropsy. The acute oral median lethal dose (LD₅₀) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight.